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Harika Enjamuri

22nd Mar · SEBI-Registered Analyst

Alkem Strengthens EU Market Access with Key GMP Approval

ALKEM
has secured a significant regulatory milestone as its Daman manufacturing facility received the European Union Good Manufacturing Practice (EU GMP) compliance certificate from the Malta Medicines Authority, following an inspection conducted on December 9, 2025; the certification, valid for 3 years starting December 9, 2025, confirms that the facility meets stringent EU quality standards, enabling smoother entry into European markets, and the company officially disclosed this development on March 20, 2026, reinforcing its compliance strength and global expansion strategy while maintaining adherence to regulatory frameworks under SEBI norms.

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